Precision Oncology Clinical Diagnostic Study In Primary and Metastatic Breast Cancer (PRISM)
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Trials Ireland
About this trial
This study aims to provide information about the genomics of your breast cancer which your oncologist can use to enhance the treatment of your disease possibly enabling more targeted and personalised therapy.This study will carry out TruSight Oncology Comprehensive (TSOComprehensive) testing on breast cancer tumour tissue that was collected at the time of your breast cancer diagnosis or during your breast surgery or if you have brain metastasis and you have had a biopsy for this. The TruSight Oncology Comprehensive assay is a next-generation sequencing (NGS) test used to analyse cancer-related genomic changes in patients, offering a comprehensive view of potential mutations and other alterations that can impact treatment decisions. The TruSight Oncology Comprehensive assay is CE-IVD marked for use in Europe, meaning that it complies with the relevant EU regulation, for comprehensive genomic profiling for different types of cancer. It analyses 523 cancer-relevant genes from both DNA and RNA to identify variations. It will also look for changes and mutations which may affect cell growth and stability. By identifying relevant mutations and biomarkers, the assay can help oncologists select the most appropriate treatment strategies with the aim of improving patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue. Or Patients with suspected or confirmed brain metastatic breast cancer (Patient has a history of a biopsy or surgically (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of their tumour tissue. Or Patients with suspected (but not necessarily biopsy confirmed) newly diagnosed brain metastatic breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue.
Patients receiving neoadjuvant treatment are also eligible (if applicable).
Patients must be ≥ 18 years of age.
Patients must be able to give informed consent.
Disqualifiers
Patients who do not have a confirmed diagnosis of primary breast cancer.
Patients whose participation, in the opinion of the PI, would not be in their best interest, or those whom in the opinion of the PI would be unsuitable for study for reasons of infirmity or poor health.
Trial design
Design model
Single group
Treatments tested in this trial
TSO500 Assay
Diagnostic testUtilisation of TSO500 assay to identify somatic, clinically actionable somatic in the primary breast tumour and, where relevant, brain metastatic tumour to the treating physician to inform clinical management of participating patients.
Treatment groups
1,600 Participants
are divided into 1 treatment groupGroup A: Experimental: Intervention: TSO 500Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of enrolled patients with at least one clinically actionable mutation identified by PRISM diagnostics compared with standard-of-care diagnostics.
Time frame
At the time of therapeutic decision following diagnostic assessment (up to 6 weeks from enrollment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cancer Trials Ireland
Lead sponsor
Royal College of Surgeons, Ireland
Collaborator
Source ClinicalTrials.gov